Vibration Training and Pelvic Floor Muscle Strength in Females With Stress Urinary Incontinence

Whole Body Vibration Plate Therapy and Pelvic Floor Muscle Strength in Females With Stress Urinary Incontinence

Pelvic floor muscle training (PFMT) is the first line therapy recommended by NICE for the treatment of SUI. Due to poor motivation and compliance only 15-20% of women comply with the regimen. Whole body vibration (WBV) exercise has been developed as a new modality in the field of physiotherapy. The Galileo machine is a unique device for applying whole-body vibration. The investigators are currently using this therapy as an alternative to traditional pelvic floor muscle therapy. The investigators aim to audit the investigators treatment of whole body vibration.

Study Overview

• Status: Completed
• Conditions: Urinary Stress Incontinence
• Intervention / Treatment: Other: Whole body vibration therapy

Detailed Description

Pelvic floor muscle training (PFMT) is the first line therapy recommended by NICE for the treatment of SUI. It was first described by Arnold Kegel almost 60 years ago. PFMT exercises help the patient strengthen the muscles of the pelvic floor by the repeated high-intensity, rapid pelvic muscle contractions of both slow and fast twitch muscle fibres. The training of these muscles is difficult particularly when women have trouble in the perception of their PFM. This results in poor motivation and compliance with a Cochrane review suggesting that only 15-20% of women comply with the regimen.

Whole body vibration (WBV) exercise has been developed as a new modality in the field of physiotherapy. Whole body vibration (WBW) has a positive effect on muscle strength and rate of force. Stochastic WBV causes up to 12 muscle contractions per second which cannot be achieved by routine PFM exercise with supervision of a physiotherapist. The Galileo machine is a unique device for applying whole-body vibration. The investigators aim to audit their treatment of whole body vibration. This would be done using the patient global impression of improvement scale (PGI-I) and routine quality of life and symptoms questionnaires (International Consultation on Incontinence Female lower Urinary Tract Symptoms Questionnaire -ICIQ-FLUTS and Pelvic Floor Distress Inventory - PFDI) to be completed by the patient at initial appointment and 12 weeks after treatment and pelvic floor muscle assessment carried out at initial appointment and at 12 weeks. Patients will also have a qualitative interview with the Urogynaecology team to assess if therapy was found to be suitable and acceptable to patients.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Gillingham, Kent, United Kingdom, ME7 5NY
      • Medway Maritime Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Stress predominant urinary incontinence
2. Female patients >18 years

Exclusion Criteria:

1. Urgency predominant urinary incontinence
2. Symptomatic pelvic organ prolapse requiring intervention
3. Patients with bladder pathology (eg haematuria of unknown origin, UTI)

4. Contraindication to Whole Body Vibration

   • Musculoskeletal

     • Hip or knee endoprosthesis
     • Acute disc herniation
     • Joint fusion with metal implants
     • Acute arthritis
     • Osteoporosis with vertebral fracture
     • Recent Fracture
     • Acute Soft Tissue Injury
     • Acute Rheumatoid Arthritis

   • Cardiovascular

     • Recent myocardial infarction
     • Hypertension
     • Serious cardiovascular disease
     • Artificial heart valves
     • Pacemaker
     • Venous Thrombosis
     • Aortic Aneurysm
     • Peripheral vascular disease
     • Untreated orthostatic hypotension
     • Hernia

   • Neuromuscular

     • Impaired sensation
     • Impaired cognition
     • Deep brain and spinal cord stimulators

   • Other

     • Malignant tumours
     • Acute oedema
     • Impaired skin integrity of foot or leg
     • Recent surgery
     • Severe diabetes or migraines
     • Kidney and bladder stones
     • Pregnancy
     • Recently placed intrauterine devices or pins

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with stress incontinence; Patients who present to urogynaecology clinic with proven stress urinary incontinence who will be offered Whole body vibration therapy.	Other: Whole body vibration therapy; Whole body vibration therapy using the Galileo machine as therapy for pelvic floor muscle training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Improvement scale (PGI-I)	Patients will be asked answer the PGI-I questionnaire after a full 12 week course of therapy	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Female lower Urinary Tract Symptoms Questionnaire	Patients will be asked to answer the ICIQ-FLUTS to assess symptom improvement after a full 12 week course of therapy	12 weeks
Pelvic Floor Distress Inventory - PFDI	Patients will be asked to answer the PFDI-I to assess any improvement in quality of life after a full 12 weeks	12 weeks
Qualitative interview	A qualitative interview will be conducted with the urogynaecology team to assess if patients found the new therapy suitable and acceptable.	12 weeks
Pelvic muscle contraction	Pelvic muscle contraction will be measured at Week 0 and Week 12 using a pelvic perineometer to assess any improvement in pelvic muscle strength	12 weeks

Collaborators and Investigators

• Sponsor: Medway NHS Foundation Trust
• Investigators: Principal Investigator: Jonathan RA Duckett, FRCOG, Medway Maritime Hospital NHS Trust

Publications and helpful links

General Publications

• Goode PS, Burgio KL, Locher JL, Roth DL, Umlauf MG, Richter HE, Varner RE, Lloyd LK. Effect of behavioral training with or without pelvic floor electrical stimulation on stress incontinence in women: a randomized controlled trial. JAMA. 2003 Jul 16;290(3):345-52. doi: 10.1001/jama.290.3.345.
• Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47.
• Luginbuehl H, Lehmann C, Gerber R, Kuhn A, Hilfiker R, Baeyens JP, Radlinger L. Continuous versus intermittent stochastic resonance whole body vibration and its effect on pelvic floor muscle activity. Neurourol Urodyn. 2012 Jun;31(5):683-7. doi: 10.1002/nau.21251. Epub 2012 Mar 6.
• Kawanabe K, Kawashima A, Sashimoto I, Takeda T, Sato Y, Iwamoto J. Effect of whole-body vibration exercise and muscle strengthening, balance, and walking exercises on walking ability in the elderly. Keio J Med. 2007 Mar;56(1):28-33. doi: 10.2302/kjm.56.28.
• Vella M, Nellist E, Cardozo L, Mastoroudes H, Giarenis I, Duckett J. Does self-motivation improve success rates of pelvic floor muscle training in women with urinary incontinence in a secondary care setting? Int Urogynecol J. 2013 Nov;24(11):1947-51. doi: 10.1007/s00192-013-2115-x. Epub 2013 May 24.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 18, 2014

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: stress urinary incontinence; pelvic floor muscle training; Whole body vibration therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: MedwayNHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO